Medical Device Importers and Manufacturers Get Updated FDA Guidance on Reporting
The Food and Drug Administration has made available a draft guidance that describes and explains the current regulation on reporting and recordkeeping requirements applicable to importers and manufacturers of medical devices for certain device-related adverse events. Comments should be submitted no later than Oct. 7.
The FDA states that this draft guidance is intended to update its policy and further clarify its interpretations of the regulatory requirements. It also provides answers to frequently asked questions and includes a section on common reporting errors. However, the guidance does not create or confer any rights for or on any person and does not bind the FDA or the public. Alternative approaches to reporting may be used if they satisfy the requirements of the applicable statute and regulations.